NCT05382871进行中（未招募）3 期
A Randomized, Double-Blinded, Cohort Clinical Study on Evaluating the Safety and Immunogenicity of Sequential Immunization of Two Doses of BIBP Inactivated COVID-19 Vaccine (Omicron), WIBP Inactivated COVID-19 Vaccine (Omicron) or Inactivated COVID-19 Vaccine (Prototype) in Population Aged 18 Years and Above Who Have Completed Two or Three Doses of Inactivated or mRNA Vaccine
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,804
- 试验地点
- 1
- 主要终点
- The Geometric Mean Titer （GMT） of anti-omicron neutralizing antibody
研究概览
简要总结
This trial adopts a randomized, double-blind and positive control design, it is planned to recruit 1800 healthy participants who have been vaccinated with 2/3 doses of COVID-19 inactivated vaccine or mRNA vaccine for 3 months. The participants will be divided into two strata according to the types of vaccines administered, including 900 participants of COVID-19 inactivated vaccine and 900 participants of mRNA vaccine. According to the ratio of 1:1:1, each stratum was randomly assigned to three groups: sequential BIBP- COVID-19 inactivated vaccine (Omicron), WIBP-COVID-19 inactivated vaccine (Omicron) or COVID-19 inactivated vaccine (prototype strain). And according to D0, D28 immunization schedule, two doses of corresponding group vaccines are sequentially administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range: populations aged 18 years and above.
- •Judged by the investigator that the health condition is well after inquiry and physical examination.
- •Vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine or mRNA vaccine for ≥ 3 months.
- •Female participants who are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 7 months after enrollment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
- •During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan.
- •With self ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and is able to comply with the requirements of the clinical study protocol.
排除标准
- •Confirmed cases, suspected cases or asymptomatic cases of COVID-19;
- •With a history of Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS) (self-report, on-site inquiry);
- •Has vaccinated with one or four doses and above COVID-19 vaccine;
- •Axillary temperature ≥37.3℃ (Tympanic temperature ≥ 37.6 ℃);
- •Previous allergic reactions to drug or vaccination (such as acute allergic reactions, urticaria, eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known components of COVID-19 vaccine (self-report, onsite enquiry);
- •Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders (self-report, onsite enquiry);
- •With known immunological impairment or immunocompromised diagnosed by the hospital (self-report, onsite enquiry);
- •Have an uncontrolled epilepsy and other progressive neurological diseases or a history of Guillain-Barre syndrome (self-report, onsite enquiry);
- •Received whole blood, plasma and immunoglobulin therapy within 1 month (self-report, onsite enquiry);
- •Known or suspected severe illness includes: respiratory illness, acute infection or active attacks of chronic illness, liver and kidney disease, severe diabetes mellitus, malignant tumor, infectious or allergic skin disease, Human Immunodeficiency Virus (HIV) infection (self-report, onsite enquiry, provide test report if available);
- •With hospital-diagnosed serious cardiovascular diseases (cardiopulmonary failure, drug-uncontrolled hypertension (physical examination of systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg), acute attacks of chronic respiratory illness (self-report, onsite enquiry);
- •Received live attenuated vaccines within 1 month before vaccination (self-report, onsite enquiry);
- •Received inactivated vaccines within 14 days before vaccination (self-report, onsite enquiry);
- •Participating or planning to participate in other interventional vaccine clinical trials during this study
- •Other vaccination-related contraindications considered by investigators.
结局指标
主要结局
The Geometric Mean Titer （GMT） of anti-omicron neutralizing antibody
时间窗: 28 days after sequential vaccination of 2 doses
The 4-fold rise rate of anti-omicron neutralizing antibody
时间窗: 28 days after sequential vaccination of 2 doses
次要结局
- Specific cellular immune response(within 28 days after vaccination)
- The GMT of anti-omicron Immunoglobulin G (IgG) antibody(28 days after sequential vaccination of 2 doses)
- The 4-fold rise rate of anti-omicron neutralizing antibody(14 days after sequential vaccination of 2 doses)
- The incidence of any adverse reactions/events(28 days after each immunization)
- The incidence of serious adverse events (SAE) and adverse events special interest (AESI)(from 1st booster dose and up to 6 months following 2nd booster dose)
- The GMT of anti-omicron neutralizing antibody(14 days after sequential vaccination of 2 doses)
- The proportions of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64(28 days after sequential vaccination of 2 doses)
- The proportion of subjects with neutralizing antibody GMT ≥1:16，≥1:32 and ≥1:64(on 3rd month, 6th month, 9th month, and 12th month after vaccination)
研究者
研究点 (1)
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